NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

AirTight: A Prospective Controlled Post-Approval Study of NeoMend ProGEL™ Pleural Air Leak Sealant in the Treatment of Visible Pleural Air Leaks After Standard Pleural Closure

The purpose of this post approval study is to further characterize the safety profile of the ProGEL™ Pleural Air Leak Sealant in commercial use, with specific reference to long-term safety over 90 days of follow-up.

Patients having open thoracotomy involving lung resection surgery will be considered for the study. Subjects will be examined for adverse events and complications from either the treatment or the procedure. Follow-up visits are required at 30 days and 90 days after the surgery.

Inclusion Criteria:

• Scheduled for an open thoracotomy for lung resection
• Has at least one or more intraoperative visible air leak >= 2 mm following the lung resection surgery

Exclusion Criteria:

• Pregnant or breast feeding
• History of an allergic reaction to Human Serum Albumin
• Has a significant clinical disease or condition
• Had previous open thoracotomy procedures
• Unable to participate in all necessary study activities due to physical or mental limitations